Phase 3 Primary Biliary Cholangitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are aged 18 or older but under 80 years old.
• You have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least 2 of the following: abnormal liver enzyme levels (ALP), certain specific antibodies found in your blood, or a liver biopsy showing signs of PBC.
• You have been taking a medication called UDCA (ursodeoxycholic acid) for at least 12 months, at a stable dose for the last 3 months.
• Your blood test results show that UDCA is not working well enough — meaning certain liver markers (ALP, GGT, ALT, AST, or bilirubin) have been above normal levels on at least 2 occasions in the past 3 months.
• If you are a woman who could become pregnant, you must be willing to use at least one barrier method of contraception during the study and for at least 90 days after the last dose.
• You are covered by a social security system (certain exemptions apply — confirm with trial site).
• You are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

• You have signs of advanced liver disease, such as very high bilirubin, low albumin, low platelet count, poor blood clotting, a Child-Pugh score of B or C, a MELD score of 14 or above, a serious liver complication in the past 2 years, or you are on a waiting list for a liver transplant.
• Your kidneys are not working well enough (below a certain level of kidney function — confirm with trial site).
• A muscle enzyme in your blood called CPK is more than 5 times the upper limit of normal.
• Your liver enzymes AST or ALT are more than 3 times the upper limit of normal.
• You have previously had a liver transplant.
• You have a condition called autoimmune hepatitis overlapping with PBC, confirmed by certain blood tests and/or a liver biopsy.
• You have another chronic liver condition, such as hepatitis B or C, fatty liver disease, alcohol-related liver disease, or certain inherited liver conditions.
• You have an untreated thyroid condition (either underactive or overactive thyroid).
• You have a condition that can raise ALP levels for reasons unrelated to the liver, such as Paget's disease or certain bone or parathyroid disorders.
• You have a condition called Gilbert's syndrome or a blood condition causing high bilirubin for reasons other than liver disease.
• You have a current, previous, or suspected diagnosis of liver cancer.
• You have been diagnosed with or treated for any other cancer in the past 2 years (some minor skin cancer treatments may be allowed — confirm with trial site).
• You have a serious illness that may significantly shorten your life expectancy.
• You are pregnant or breastfeeding.
• You are known to be intolerant or allergic to bezafibrate, any of its ingredients, or other fibrate medications.
• You have a known sensitivity to light (photosensitivity) caused by fibrate medications.
• You have certain rare conditions affecting how your body processes lactose or glucose (confirm with trial site).
• You have taken part in another clinical trial in the past 6 months.
• You have taken certain medications in the past 3 months, including bezafibrate, other fibrates, obeticholic acid, steroids, or certain immune-suppressing drugs (confirm with trial site for the full list).
• You have taken statin medications (cholesterol-lowering drugs) in the past month.

Important: Always verify eligibility with the trial site directly before applying.